Athena Pelvic Muscle Trainer - DUETS Trial
- Conditions
- Urinary Incontinence
- Registration Number
- NCT01073878
- Lead Sponsor
- Athena Feminine Technologies, Inc.
- Brief Summary
The purpose of this study is to determine if the Athena Pelvic Muscle Trainer device effectively treats stress, urge or mixed incontinence in women by strengthening the pelvic floor muscles by collecting data from the patient on the
1. Over Active Bladder Questionnaire
2. The 7-Day Urine Diary questionnaire
This study will also look at whether or not there is an improvement in sexual health after using the device by collecting data frm the patient on the
3. Female Sexual Function Index questionnaire
- Detailed Description
This is a Phase IV, prospective, open-label, multi-center, observational study to assess the effectiveness of the Athena PMT to relieve or eliminate the symptoms of female urinary incontinence.
The study will enlist approximately 100 or more Nurse-Practitioners in Women's Health as the principle investigators from community-based primary care centers (OB-GYN, Internal Medicine, Family Practices or Women's Health Centers) who will enroll approximately 500 or more subjects who suffer from urge and/or stress urinary incontinence and who may benefit from strengthening of Kegel muscles of the pelvic floor.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 462
- Women between the ages of 30 and 70 years
- Suffer from urge-incontinence, stress incontinence or incontinence of mixed etiology and who may benefit from strengthening Kegel muscles by electrical stimulation
- Able to provide informed consent and physically able to comply with protocol requirements.
- Experience one or more incontinence episodes per week.
- Women of childbearing potential must have a negative urine or blood pregnancy test within 7 days prior to initiation of treatment.
- Subject may be post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (e.g., hormonal contraceptive, intra- uterine device (IUD), diaphragm with spermicide, condom with spermicide or abstinence) from the screening visit through the duration of study participation.
- Have a positive response to two or more questions on the Athena Questionnaire
- Neurological deficiency that does not permit proper sensory perception or stimulation.
- Is currently pregnant, lactating or attempting to get pregnant
- Has a cardiac pacemaker or a history of rate or conductive disturbance
- Has anatomical vaginal structures that do not permit proper and complete placement of the trainer.
- Has irregular menstrual bleeding cycles.
- Has urinary or vaginal infections, localized lesions, or other undiagnosed symptoms.
- Has a history or symptoms of urinary retention.
- Has cancer or a life expectancy of less than one year
- Recreational drug use
- Consume more than three caffeine beverages daily
- Consume more than 1-2 alcoholic drinks per day
- Significant drug use (causing diuresis or urinary retention
- Allergy or sensitivity to materials in the Athena PMT
- Participation in another clinical trial within past 3 months
- Subjects morbidly obese (BMI >35)
- Subjects who chronically smoke (> 10 cigarettes per day)
- Subjects required to do heavy lifting (> 40 pounds regularly)
- Surgery within the past six months for incontinence, or use of other incontinence devices
- Currently taking cholinergic or anti-cholinergic drugs or other prescription or non-prescription drugs that may increase or decrease the volume or frequency of urination and thus, may confound the results of this study, except, in the opinion of the investigator. The subject's regimen has been stable for at least sixty days.
- Suspected infection or condition (e.g., diabetes) that would alter the subjects ability to participate or would confound the results of the trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To assess objective treatment outcomes of urge, stress or mixed incontinence. 5 Visits over 13 weeks. Subjects are seen in the office at Screening Visit 1 (Week -1), Visit 1a (Week 0), Visit 2 (Week 2), Visit 3 (Week 6), Visit 4 (Week 12) Outcomes will be measured via patient questionnaires over a 13 week trial. Visit 1 (Week -1) and Visit 4 (Week 12) values for the Overactive Bladder Questionnaire and the Female Sexual Function Index will be captured. 7-day Urine Diaries will be captured for the week preceeding visits 2, 3 and 4.
- Secondary Outcome Measures
Name Time Method Evaluate effectiveness, tolerability, satisfaction and compliance of the Athena PMT across a wide demographic population using: 1) the Subject Satisfaction Evaluation questionnaire At Visit 4 (Week 12) At the last visit, patients will complete a Subject Satisfaction Survey.
Trial Locations
- Locations (97)
Kathryn Cervi
🇺🇸Columbia, Maryland, United States
Holly Murphy
🇺🇸Columbus, Ohio, United States
Columbus OB/Gyn Inc.
🇺🇸Columbus, Ohio, United States
Susan Frost
🇺🇸Columbus, Ohio, United States
Laura C. Maw
🇺🇸Lehi, Utah, United States
Rand Gynecology, LLC
🇺🇸Chesapeake, Virginia, United States
Primary Care, PLLC
🇻🇮Christiansted, Virgin Islands (U.S.)
Patrice C Malena
🇺🇸Newport News, Virginia, United States
Betsy Browning
🇺🇸Bennington, Vermont, United States
Kimberly Scheer
🇺🇸Vashon, Washington, United States
Ocean Beach Women's Clinic
🇺🇸Ilwaco, Washington, United States
D. Crawford Allison MD
🇺🇸Waco, Texas, United States
Anne L Stephens
🇺🇸Chesapeake, Virginia, United States
Kathy Edwards
🇺🇸Minot, North Dakota, United States
John Foster MD
🇺🇸Birmingham, Alabama, United States
La Mamma Spa
🇺🇸Birmingham, Alabama, United States
Evan Vapnek MD
🇺🇸San Diego, California, United States
Urology Associates, P.C.
🇺🇸Nashville, Tennessee, United States
Christopher J. Jayne, MD, FACOG
🇺🇸Houston, Texas, United States
Urology San Antonio
🇺🇸San Antonio, Texas, United States
Marney Kidwell RNC
🇺🇸San Antonio, Texas, United States
Julie Spencer
🇺🇸Lansdowne, Virginia, United States
Kyle Chavers MD
🇺🇸Dothan, Alabama, United States
Salud! for Women
🇺🇸Casa Grande, Arizona, United States
Arcadia Well Woman
🇺🇸Scottsdale, Arizona, United States
Patricia A Faust
🇺🇸Tempe, Arizona, United States
Teresa Mote RNC NP
🇺🇸Tucson, Arizona, United States
Lynda Reed
🇺🇸Ontario, California, United States
Beth Andresen
🇺🇸Tucson, Arizona, United States
Healthworks
🇺🇸San Luis Obispo, California, United States
Maureen Allen
🇺🇸Northglenn, Colorado, United States
Rose Mary Mosher
🇺🇸Rolling Hills Est., California, United States
Brenda Hanson-Smith, RN, DNS, OGNP
🇺🇸El Dorado Hills, California, United States
Marilyn Brooks
🇺🇸San Jacinto, California, United States
Kristan Langdon, ANP-C
🇺🇸Parker, Colorado, United States
Merrilyn H. McNatt APRN
🇺🇸New London, Connecticut, United States
Karen D. Adamson
🇺🇸Salida, Colorado, United States
Jean Ohliger APRN
🇺🇸South Windsor, Connecticut, United States
Arlena Falcon
🇺🇸Blountstown, Florida, United States
Carl Spirazza
🇺🇸Boynton Beach, Florida, United States
Ivonne M. Reynolds
🇺🇸Margate, Florida, United States
Susan Chappuis, ARNP-C
🇺🇸Ormond Beach, Florida, United States
Khadra Mohamoud Osman mD
🇺🇸Ft. Lauderdale, Florida, United States
Bayside Gynecology, P.A.
🇺🇸Venice, Florida, United States
Shelly E Kramer ARNP
🇺🇸Lake Worth, Florida, United States
Elizabeth Tsarnas
🇺🇸Stuart, Florida, United States
Jeffrey C Seiler, MD
🇺🇸West Palm Beach, Florida, United States
Michael D Benson
🇺🇸Deerfield, Illinois, United States
Elizabeth Killebrew MD
🇺🇸Fayetteville, Georgia, United States
Sherry Owen, APN
🇺🇸Gurnee, Illinois, United States
Deborah Cothran WHNP-BC
🇺🇸Albany, Georgia, United States
Laurie Knoke
🇺🇸DeKalb, Illinois, United States
Julie Snow
🇺🇸Park Ridge, Illinois, United States
Tammi K Herkey
🇺🇸Bossier City, Louisiana, United States
Kathryn A. Copeland
🇺🇸Carmel, Indiana, United States
Matthew Sprunger MD
🇺🇸Fort Wayne, Indiana, United States
Tamara Meisel ARNP
🇺🇸Lakin, Kansas, United States
Richard F. Ford MD
🇺🇸Ashland, Kentucky, United States
Elizabeth P Sipala
🇺🇸Galena, Maryland, United States
Steven Lenowitz, MD
🇺🇸Bel Air, Maryland, United States
Deborah A. Davis, MSN, CRNP
🇺🇸Prince Frederick, Maryland, United States
Pioneer Valley Urology
🇺🇸Springfield, Massachusetts, United States
Martha Klay
🇺🇸Gt. Barrington, Massachusetts, United States
Margaret Duggan
🇺🇸Walpole, Massachusetts, United States
Kathleen M. Young RNC NP
🇺🇸Kalispell, Montana, United States
Isabel M Raposo
🇺🇸Riverview, Michigan, United States
Kathryn Koches
🇺🇸Dearborn, Michigan, United States
Mickie G. Autry PhD, NP-C
🇺🇸Jackson, Mississippi, United States
Women's Health Care Specialists, PC
🇺🇸Paw Paw, Michigan, United States
Laura Hintz
🇺🇸Saginaw, Michigan, United States
Meredith Schledorn
🇺🇸Cortland, New York, United States
Jeanne Ann Dahl, RNC, WHNP
🇺🇸Albany, New York, United States
Women's Total Health
🇺🇸Hamburg, New Jersey, United States
Cindy Nevara APN
🇺🇸Vineland, New Jersey, United States
Lynda M. Adamson
🇺🇸Galloway, New Jersey, United States
Urogynecology Arts of New Jersey
🇺🇸East Brunswick, New Jersey, United States
Raj Mahajan MD
🇺🇸Oswego, New York, United States
Diane Stonemetz
🇺🇸W. Seneca, New York, United States
Amy G Brenner M.D
🇺🇸Fairfield, Ohio, United States
Elizabeth D. Allen CNP
🇺🇸Gallipolis, Ohio, United States
Deborah Malone
🇺🇸Bend, Oregon, United States
Anne Marie Moore, Womens Health Nurse Practitioner
🇺🇸Eugene, Oregon, United States
Cathleen Ann Folk FNP
🇺🇸Portland, Oregon, United States
William Shuler, MD
🇺🇸Tulsa, Oklahoma, United States
Mary L Hagood, FNP-C
🇺🇸Roseburg, Oregon, United States
Marie T Ziegler
🇺🇸West Chester, Pennsylvania, United States
Paulette Schreiber, CRNP
🇺🇸St. Mary's, Pennsylvania, United States
Institute for Female Pelvic Medicine
🇺🇸Allentown, Pennsylvania, United States
Nancy Newman RNC, WHNP
🇺🇸Lexington, South Carolina, United States
John Pickel MD
🇺🇸Arlington, Texas, United States
Agnes Oblas APRN
🇺🇸Phoenix, Arizona, United States
Stefanie A Schultis
🇺🇸Covington, Louisiana, United States
Barbara Wiggin PhD, ANP-C
🇺🇸Peoria, Arizona, United States
Sharon Little
🇺🇸Collierville, Tennessee, United States
Margaret A. Hull
🇺🇸Franklin, Tennessee, United States
New Horizons Women's Care
🇺🇸Chandler, Arizona, United States
Women's Care Center
🇺🇸Lexington, Kentucky, United States